Bionic Leg Orthosis User Manual - AlterG · AlterG Bionic Leg User Manual 116569 Rev B Page 4 of 53 1. Purpose 1.2. Indications for Use The AlterG Bionic Leg Orthosis is designed

Bionic Leg Orthosis

User Manual

P/N: 116569 Rev B

Oct 2018

ECO-TBD

European Authorized

Representative

Obelis s.a.

Bd. Général Wahis 53

B-1030 Brussels, Belgium

Phone: 32.2.732.59.54

Fax: 32.2.732.60.03

E-mail: [email protected]

AlterG, Inc.

48438 Milmont Dr.

Fremont, CA 94538

www.alterg.com

Office: 1-510-270-5900

Support: US: +1.510.270.5369

UK: +44 (0)7733 179187

Fax: 1-510-225-9399


mailto:[email protected]

http://www.tibion.com/

AlterG Bionic Leg User Manual

116569 Rev B Page 2 of 53

Table of Contents

1. PURPOSE ............................................................................................................ 4

1.2. INDICATIONS FOR USE .................................................................................... 4 1.3. CONTRAINDICATIONS TO USE ........................................................................... 4

2. SAFETY INSTRUCTIONS ................................................................................ 5

2.1. WARNINGS AND CAUTIONS .............................................................................. 5 2.2. DEVICE LABELING AND ICON DESCRIPTION ................................................. 9 2.3. AUDIO NOTIFICATIONS .................................................................................... 14

3. PRODUCT DESCRIPTION AND FUNCTION ....................................... 15

3.1. PRODUCT DESCRIPTION ................................................................................ 15 3.2. PRODUCT OVERVIEW ....................................................................................... 16 3.3. USER INTERFACE ............................................................................................. 17 3.4. SHOE INSERT ................................................................................................... 18 3.5. DEVICE ORTHOSIS ......................................................................................... 18 3.6. OPERATING MODE........................................................................................... 21 3.7. CONFIGURABLE OPERATING PARAMETERS ................................................ 23

4. INSTRUCTIONS FOR USE ........................................................................ 25

4.1. DONNING INSTRUCTIONS .............................................................................. 25 4.2. REMOVAL INSTRUCTIONS ............................................................................. 31 4.3. SET-UP INSTRUCTIONS ................................................................................. 32 4.4. CLINICAL APPLICATION ................................................................................ 34 4.5. ADDITIONAL INTERFACE FEATURES ........................................................... 36

5. REMOVABLE BATTERY AND BATTERY CHARGER ...................... 38

5.1. BATTERY TYPE ............................................................................................... 38 5.2. BATTERY CAPACITY ........................................................................................ 38 5.3. SPECIFICATIONS, ENVIRONMENTAL AND SAFETY .................................... 38 5.4. CHANGING THE BATTERY .............................................................................. 39 5.5. BATTERY CHARGER ....................................................................................... 40 5.6. CHARGING THE BATTERY ................................................................................ 40 5.7. BATTERY LABELING ...................................................................................... 40

6. ENVIRONMENTAL AND SAFETY CONDITIONS ............................. 43

6.1. OPERATING CONDITIONS................................................................................. 43 6.2. STORAGE AND TRANSPORTATION ................................................................... 43



6.3. SAFETY SPECIFICATIONS ................................................................................. 43 6.4. CARE AND MAINTENANCE ............................................................................... 43

7. TROUBLESHOOTING .................................................................................... 45

7.1. ERROR CODES ................................................................................................ 45 7.2. OPERATIONAL ISSUES ...................................................................................... 46 7.3. FITTING ISSUES ................................................................................................ 50

8. WARRANTY AND SERVICE ........................................................................ 51

8.1. WARRANTY ...................................................................................................... 51 8.2. CUSTOMER SERVICE ........................................................................................ 52

9. CONTACT ......................................................................................................... 53



1. Purpose

1.2. Indications for Use The AlterG Bionic Leg Orthosis is designed to provide temporary active external

support and stability assistance for individuals who have impaired lower extremity

function.

The Bionic Leg is a prescriptive Device. It cannot be ordered except by Medical

professionals.

1.3. Contraindications to Use The AlterG Bionic Leg should not be used with individuals with unhealed bone

fractures or at risk of fracture as a consequence of osteoporosis or bone cancer.

Individuals with the following on the intended limb should also not use the Bionic

Leg: open wounds, fragile skin, deep vein thrombosis (DVT), unstable

cardiovascular conditions, incontinence, or those who are on contact precautions for

infection.



2. Safety Instructions

2.1. Warnings and Cautions IMPORTANT: For your safety, basic precautions should always be followed when

using this device. Read all instructions, especially safety warnings, before using the

device. Save this guide for future use.

SAFETY WARNING

THESE SAFETY PROCEDURES MUST BE FOLLOWED TO AVOID

INJURY

• Use this product only for its intended use and only as described in this

manual.

• Always visually inspect the device (including foot insert, cable, and

connector) for damage before use.

• If there are any signs of damage to the device or accessories, do not use.

• Use the AlterG Bionic Leg only within the range of motion and level of

assistance that is safe for the user’s condition.

• Do not use the Bionic Leg if the user has fragile skin, open lesions, or

blisters in the vicinity of where the device will be placed.

• Footwear must be worn when using the AlterG Bionic Leg. Failure to do

so may affect device performance and/or cause injury to the patient.

• Avoid over-tightening any part of the device around the user’s lower

extremity. This may reduce blood circulation to the limb and potentially

cause swelling, paresthesia (tingling or numbness), tissue death, or other

symptoms.

• Discontinue use of the device if the user experiences irritation, swelling,

pain, or other similar symptoms in the lower extremity wearing the Bionic

Leg.

• Discontinue use of the device if the user has sustained an injury that may

affect their ability to use this product safely.

• Do not use (or discontinue use of) the device if the user experiences any

unusual cardiovascular responses or feels dizzy, lightheaded or nauseated.

• Keep fingers away from all moving components of the AlterG Bionic Leg

orthosis.

• Remove obstructions from the path of the user’s motion.

• The device is not to be turned off while supporting end-user ambulation.

• The device battery is not to be removed while supporting end-user

ambulation.



• Always use caution and have assistance when the user is training on

stairs. Users should always use a railing or assistive device (cane, walker,

etc.) when using the Bionic Leg on stairs.

• Always follow basic safety precautions when using electrical products to

avoid electric shock, burns, or fire.

• Do not use the Battery Charger or the Power Supply if either appears

damaged or is not working properly.

• The Removable Battery (P/N: 19-00015-00) contains a Lithium Ion power

cell. The Battery must be disposed of (or recycled) in accordance with local

regulations. Do not dispose of the Battery in the trash or fire.

• When using the Battery Charger, attach only the Power Supply that is

provided.

• During charging the Battery Charger may become warm. Place the

Charger in a cool spot, away from external heat sources (such as direct

sunlight, or other electronic devices).

• Keep the Battery Charger’s power cord away from heated surfaces.

• Do not immerse the Battery or Charger in water. Do not expose the

Charger or Power Supply to water or liquids.

• Do not open the Charger or Power Supply case; no user serviceable parts

are inside.

• Always remove the Battery when device is shipped via air or ground

transport.

• Never attempt to open, disassemble, modify, or repair any component of

the AlterG Bionic Leg, including accessories. Contact AlterG Customer

Service for all service related concerns.

• If the AlterG Bionic Leg has a serious malfunction, remove the Battery or

use the Main ON/OFF switch to disconnect power from the device.

Contact AlterG Customer Service immediately.

• If the AlterG Bionic Leg becomes too warm, turn off the device using the

Main ON/OFF switch. Remove device from the user. Contact AlterG

Customer Service immediately.

• If user’s safety is threatened by fire, natural disaster, or other emergency,

DO NOT turn off the device. Use the AlterG Bionic Leg to help escape the

emergency situation calmly. Activation of the ON/OFF switch or Standby

button may result in limited range of motion, posing an additional obstacle

to an evacuation.

ATTENTION

PLEASE FOLLOW THESE INSTRUCTIONS TO AVOID

DAMAGING THE DEVICE



• Exercise caution and use good clinical judgment when using the Bionic Leg.

• If the Shoe Insert is not fitted properly (e.g. Footpad is wrinkled or folded

under the foot), the device may be unable to gather correct information from

the sensors and therefore may not perform as expected.

• Always store the Shoe Inserts in a place where they can remain flat. While the

Footpad is designed to flex under the user’s foot, avoid bending or folding the

Footpad in order to prevent damaging the embedded sensors.

• It is recommended, but not required, that the Anklet be positioned to cover the

Footpad Cable Connector to provide a barrier and protect the connector from

inadvertent damage during use.

• Handle this product with care. Avoid dropping or hitting the device against

hard surfaces.

• Store the device in its protective case in a clean, dry location.

• Avoid storage locations subject to excessive temperatures or humidity (see

section 6.2).

• Follow the instructions in this manual to clean the device.

• Do not saturate or submerge the AlterG Bionic Leg or its accessories in fluid of

any kind.

• The Bionic Leg generates, uses, and can radiate radio frequency energy and, if

not used in accordance with the manufacturer’s instructions, may cause

harmful interference to other devices in the vicinity. The device has been tested

to – and complies with -- the emission limits of the standard EN60601-1-2.

NOTE

PLEASE FOLLOW THESE RECOMMENDATIONS TO ACHIEVE

THE BEST RESULTS

• The Bionic Leg should be placed over the user’s clothes or suitable protective

barrier. Do not allow the device to directly contact the user’s skin.

• Users should wear appropriate, comfortable and supportive shoes while using

the Bionic Leg. Low profile athletic shoes or walking shoes are best.

• Be sure to firmly tighten the quick release handle after adjustment to maintain

proper alignment of device.

• A comfortable level of tightness –—as tight as possible without constriction –

—should be achieved using the cable reels. If the device is too loose it may

impact the ability of the device to efficiently transfer assistance to the user.

• Continuous activity with the device will cause the cable system to naturally

loosen over time. The cable reels should be frequently checked to maintain a

“comfortable level of tightness”.

• The “Pause” soft key or Home button can be depressed while in



Active Mode to stop the device and allow for a parameter to be adjusted by

then depressing the “Settings” soft key. To return to the Active Mode press

the Home button and then “Start” soft key.

• The Bionic Leg will always provide the user with free motion when there is no

weight on the foot. If the user wishes to disengage the device, the user should

be assisted to take the weight off the foot by lifting it off the ground.

• The battery charge icon on the Bionic Leg may not be a precise indication of

the remaining charge. Whenever possible, use a fully charged battery for each

therapy session.

At the end of the useful life of the Bionic Leg, please refer to our website for

instructions on proper disposal or return of the product.



2.2. Device Labeling and Icon Description

TABLE 1: USER MANUAL ICONS

Name Icon Description

SAFETY

WARNING

Warns the user of a potential safety hazard; follow

these instructions to avoid injury or bodily harm.

ATTENTION

Cautions the user of a potential hazard to the product;

follow these instructions to prevent product damage

and maintain proper function.

NOTE

Advises the user of important information regarding

the use of the product for the best results.

TABLE 2: DEVICE LABELS

Name Icon Type/Description

Main Power

(ON)

Switch prevents or interrupts the main power to

the device.

To turn the device on, you must slide the switch

to the ON position.

(OFF)

To disable the power to the device, slide the

switch to the OFF position.

During transport of the device, slide the switch

to the OFF position so that the device cannot be

inadvertently powered on.

Select Keys N/A Oval soft buttons that will select the function

listed on the display screen next to the button.

Home

Large round button that returns the display to

the Home menu screen and stops the device if

pressed while device is operating. If the button

is held and released for greater than 2 seconds

the display will rotate 180°.

Standby/ON

Small round button that turns the device ON or

places it in Standby/ OFF mode. To turn the

device ON, press button once. The device will

automatically start up. Press button and hold for

1-2 seconds to turn the device to Standby/OFF

mode. The device will automatically go from

ON to Standby mode if there has been no

movement or button activity for 30 minutes.


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Name Label Image

Company Name

Product Name Bionic Leg

Product Patent

Information www.alterg.com/patents

Manufacture

Operating

Instructions – Refer

to User Manual

Warning and

Precautions – Refer

to User Manual

Minimum/Maximum

Operating

Temperature

Keep Dry

Electrical and

Electronic Recycling

Required

Non-sterile Device

Product Name

Product

Certification


116569 Rev B Page 11 of 53

TABLE 3: Icon Descriptions

Icon Meaning Description Previous Text

Patient

Weight

Patient Weight lbs. or kg.

Change to/from lbs/kg in

third Information screen.

Patient Wt.

Assist %

Assistance delivered as a

percent of entered body

weight. Turns orange

near limits of assistance

Assistance

Resistance

(1/2/3)

Resistance for stair

descent or stand-to-sit.

Higher numbers give

slower descent.

Resistance

Low/Medium/High

Threshold

Start threshold as

percentage of body

weight on foot sensor in

order for device to

activate

Threshold (%)

Assist

Cutoff

Limit in degrees from

vertical when device will

cease to give assistance.

Increase this to prevent

hyperextension.

Ext. Limit (degree)

Settings

Go to settings screen to

examine/modify the five

settings above. Defaults

restored at power on or

foot sensor change.

Settings

Information

Go to information screens

for AlterG contact

information, serial

numbers, device usage,

and change of weight

units.

Left/right scroll

arrows

Help

Go to help screens for

sequence of images

showing steps of device

donning and setup.

N/A

Start

Start active assistance.

Device activates with

weight on foot sensor

above threshold with

knee angle change.

Auto


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Pause

Stop active assistance and

return to the home

(paused) screen The

home button performs the

same function.

(Press home button)

Done

Finish update of settings.

The home button

performs the same

function.

(Press Auto or Home)

Next Screen Advance to the next

settings or help screen. N/A

Previous

Screen

Go to the preceding help

screen. N/A

Device

Usage or

Session

Steps

Shows a number with the

number of repetitions or

steps. Session reps

shown while paused or

active.

Device Usage: Steps

Auto Mode:

Reps/Steps

Device

Usage

Hours

Total device hours while

in active mode. Shown on

information screen along

with total repetitions.

Device Usage: Hours

Home,

Pause,

Invert

screen

Return to home (paused)

screen. If button is held

down for several seconds,

the screen flips around.

If settings have never

been examined or

changed since defaults

were restored, the home

button goes to the

initialize screen.

(Home button)

Full Battery Battery fully charged Full Battery

Partial

Battery

Battery partially charged;

the battery has

approximately 50%

charge remaining

Partial Battery

Empty

Battery

Battery empty; the

battery should be

removed and recharged

Empty Battery


116569 Rev B Page 13 of 53

2.2.1.1. Quick Start Label

The “Quick Start Instructions” label provides quick instructions on programing and

putting the Bionic Leg on.


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2.3. Audio Notifications The Bionic Leg provides audio notifications to the user when attention may be

required on the device or when an action has completed. The different conditions

are described below:

TABLE 4: AUDIO NOTIFICATIONS

Name Description

Power On Complete initialization is indicated by a series of two

beeps

Error Single beep or series of beeps (every 5 seconds) that

persists until it is cleared on the display

Warning Notice Single beep that will clear itself

Low Battery

(< 30 % charge) Series of beeps (every 10 seconds)

Very Low Battery

(< 20% charge) Series of beeps (every 4 seconds)


116569 Rev B Page 15 of 53

3. Product Description and Function

3.1. Product Description The AlterG Bionic Leg is a non-invasive, dynamic, wearable lower extremity orthosis that is

battery-powered and portable. It acts to supplement existing muscle strength, provide sensory

inputs (i.e. auditory and sensory feedback) and mobility assistance for users with impaired

lower-extremity function during rehabilitation. The range of motion and amount of assistance

delivered by the Bionic Leg is customizable through the device settings. These parameters

are determined by the clinician.

The Bionic Leg is fitted and worn in a manner similar to an

orthopedic knee brace. The device couples two main

assemblies: a drive system and an exoskeleton.

An actuator in the internal mechanism of the Bionic Leg’s

drive system provides assistance and resistance felt by the user

during knee movement, as well as the sounds that provide

feedback. The exoskeleton is a dynamic orthosis, specifically

designed to provide support in response to weight shifts and

knee movement, as well as external support to the lower

extremity.

The Bionic Leg uses sensors, microprocessor technology and

customized software to automatically detect a user’s actions,

such as walking or climbing stairs, and allows the device to respond as needed. There are

sensors in the Shoe Insert that detect when weight is on and shifting through the foot, sending

a signal to the microprocessor. When the device detects motion at the knee hinge, the system

will then determine the required amount of assistance and activate the Bionic Leg. The user

will feel a support when extending the knee and a resistance when flexing the knee while

weight bearing. The amount of assistive/resistive support (called “Assistance” and

“Resistance” ) offered by the device will be determined by the clinician depending on the

user’s needs. In addition to the support perceived by the user, audible sounds will be heard

from the Bionic Leg as it moves forward and backward. The sounds are distinguishable and

can be used as feedback mechanisms for identifying proper movement sequences; that is,

performing knee swing into extension versus flexion and moving with a smooth, desirable

rate.


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3.2. Product Overview

3.2.1. Basic Components

3.2.1.1. Bionic Leg Orthosis

• Rigid exoskeleton lower limb

orthosis

• Drive system and housing

• Battery (removable)

• Textiles (thigh, knee, calf)

• Cable and reel system

• Finger shield

• User interface

3.2.1.2. Shoe Insert

• Foot sensor (sizes: XS, S, M, L)

• Medial and lateral stays

• Footpad Cable Connector

• Anklet

3.2.1.4. Portable Case

3.2.1.5. Removable Battery System

• Battery

• Battery Charger

3.2.2. Accessories

• Additional Rechargeable

Batteries

• Additional Shoe Inserts


116569 Rev B Page 17 of 53

3.3. User Interface

3.3.1. Components

a. Main ON/OFF power switch

b. Input selection buttons

c. Display screen

d. Home button

e. Standby button

3.3.2. Display Screen

The information displayed on the display screen

changes based on what is selected, and what

stage of set up or review you are in.

3.3.2.1. Orientation of the Display Screen

Upon initial power-up from factory default settings, the

information on the display screen is oriented so that the setting

can be easily read. The display may be rotated 180 degrees by

pressing and holding the Home button on the user interface for

approximately 2 seconds. Upon releasing the button, the

displayed information will be rotated 180 degrees. The

information will remain in this orientation until the Home

button is pressed again for 2 seconds. When the device is

restored to defaults or main power disconnected, the orientation

will revert to the default setting.

a

b

c

d

e


116569 Rev B Page 18 of 53

3.4. Shoe Insert The Shoe Insert consists of the Sensors, Footpad, Footpad Cable Connector, and

medial and lateral ankle pads. Each Footpad is dedicated to either the right or left

foot and comes in four different sizes (S, M, L, XL).

Embedded in the Footpad are force sensors that are located in the heel and forefoot

areas.

3.5. Device Orthosis The Bionic Leg orthosis consists of a dynamic exoskeleton, drive system, textiles,

adjustment cables with tightening reels, a finger shield and a cable to the Shoe

Insert. The orthosis extends from the thigh to the ankle of the user’s lower

extremity. Textiles are wrapped around the user’s thigh, knee and lower leg. These

textiles are then secured around the leg with the cable and reel fitting system. This

mechanism provides circumferential tactile snugness around the user’s lower

extremity. Lastly, the distal portion of the exoskeleton connects and stabilizes the

orthosis, near the ankle.

3.5.1. Exoskeleton

This is the rigid portion of the orthosis, which adds

strength and stability to the device.

3.5.2. Drive System

The drive system is the powerhouse of the device. It is

located under the plastic housing and comprises the

mechanisms that allow the Bionic Leg to provide

mobility assistance and audible feedback to the user.

Connector

Footpad

Sensors


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3.5.3. Textiles

The device has three distinct sections of cloth textiles, located

at the thigh, knee and lower leg. These textiles secure the

orthosis to the user’s lower extremity by wrapping around the

limb and being attached by Velcro. They are to be put on from

bottom to top (lower leg, knee, upper leg) according to the

Quick Start Guide

3.5.4. Cable and Reel System

The cable and reel system fine-tunes the

circumferential snugness of the textiles around the

user’s limb. The rotation of the reels adjusts the

tightness of the textiles.

SAFETY WARNING

Users should not open the drive system housing; access to this area

is restricted to AlterG Customer Service.

3.5.5. Finger Shield

SAFETY WARNING

AlterG Bionic Leg to be operated only with housing and finger

shields in place.

Keep all fingers and appendages away from moving components of

the AlterG Bionic Leg exoskeleton.

A finger shield is provided for safety; however, always keep fingers and appendages

away from the knee hinge joint and all other moving components of the orthosis

when the device is in use.


116569 Rev B Page 20 of 53

For Illustration Only—

keep fingers away from the locations shown.


116569 Rev B Page 21 of 53

3.6. Operating Mode Active Mode uses information from the sensors in the device to automatically

detect the user’s actions (walking, sit to stand, climbing stairs, etc.) and deliver

assistance or resistance as needed. The device will provide assistance when the

user puts sufficient weight on their foot to initiate movement; the device will then

adjust its action based on the user’s further movements.

The device can be customized to accommodate a user’s specific needs through

parameter settings described under Section 3.7.

Table 5 below, Clinical Activities, summarizes what to expect from the device

during the functional activity listed. This is not an all-inclusive list of mobility

training tasks that may be performed with the device.

TABLE 5: CLINICAL ACTIVITIES

Activity What to Expect

Sit to Stand

Once the user places sufficient weight on to the Footpad Sensors the

device will enter the “Ready” state. As the user begins to stand from a

seated position, knee angle sensors will detect the intention and the

device will respond by providing assistance with extension. The user

will feel assistance when rising.

Stand to Sit

Once the user places sufficient weight onto the Footpad Sensors the

device will enter the “Ready” state. As the user begins to transfer

from standing to sitting, the knee angle sensors will detect the

movement and the device will respond by providing assistance to

flexion. The user will feel the device “brake,” which will slow down

the user’s movement onto the seat.

Walking

Stance Phase: Once the user plants their foot on the ground and

shifts sufficient weight on to leg, the user will feel assistance to reach

full extension. The device helps the user maintain a stable extended

knee position of the involved limb in stance.

Swing Phase: At toe-off the device allows the leg to swing freely

during knee flexion. During flexion, the user may hear the motors run

in preparation for the next step, but the device does not provide active

flexion assistance. As the user swings the device leg forward, they

will experience free motion in the knee.


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Ascending

Stairs

Stepping up with the device (weak) leg: The user lifts their foot up

on the step in front of them, and shifts their weight up and forward.

The user will experience assistance with knee extension from the

device, as needed.

Stepping up with the non-device (strong) leg: The user lifts the

strong leg up on the step in front of them; the device will provide

passive assistance with maintaining knee extension and stability of

the device (weak) leg.

The user will then alternate stepping to the same or next level step.

Descending

Stairs

Stepping down using the device (weak) leg: The device leg is

securely positioned in full extension on the step. The user lifts,

swings, and lowers the non-device foot down to the step below.

During this movement, the device knee will begin to bend and the

device will resist the flexion. This action allows the patient to control

knee flexion movement and gently lower the non-device foot down

on to the step.

Stepping down with the non-device (strong) leg: Once the non-

device leg is securely placed and extended on the lower step, the user

can lift, swing, and lower the device leg to the same or next-level

step. During this movement, the non-device knee will be in control of

the descent and the device knee will be free to bend and straighten as

the user moves it down to the next step. Once the device foot is

securely placed on the step and weight is shifted over, the device may

provide extension assistance if the knee is not fully extended based on

the parameter settings. Thus, the user will experience assistance to

extension of device knee.


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3.7. Configurable Operating Parameters The Bionic Leg utilizes a set of configurable parameters, allowing customizable

performance of the device to meet the needs of individual users. These parameters

are accessible through the User Interface and are summarized in Table 6A below.

There are five parameters that can be set by the clinician: Weight ,

Threshold , Assistance , Resistance and Assist Cutoff .

TABLE 6A: CONFIGURABLE OPERATING PARAMETERS

Parameter Symbol Description Range Default

User Weight User body weight

110 to 300

lbs (50 to

135kgs)

110 lbs (50 kgs)

Threshold

Percentage of single-

limb body weight that

must be on the foot

before assistance will

be provided.

5 to 95% 30%

Assistance

Factor

Amount of assistance

(in % single-limb body

weight) provided for

knee extension.

10 to 90%* 45%

Resistance

Factor

Amount of resistance

provided during knee

flexion activities (stair

descent, sitting).

Low-Med-

High Med

Assist Cutoff

Degrees from full

extension to which the

device will provide

assistance.

0º to 120º 6º

* Assistance is a non-linear value and diminishes with heavier patients. During set-up this

is noted when the Assistance value turns orange and patients may require additional

assistance from the therapist to complete a task or prevent a possible fall.

SAFETY WARNING

The Bionic Leg provides limited assistance for heavier patients. When the

combination of Patient Weight and requested assistance exceeds

this limit, the displayed Assistance Percentage value turns orange. When you

see an orange value, the actual assistance delivered to the patient is less than


116569 Rev B Page 24 of 53

the percentage shown and extra caution should be taken to assure that the

patient is always properly supported.

Threshold is the percentage of overall body weight that is necessary through the

user’s foot to activate the device in a “ready” state before it will provide assistance.

Typically, in normal stance half of body weight (50%) is distributed in each leg. By

setting the Threshold with a lower value, the device activates with less weight

through the foot (i.e., it is more sensitive to small weight shifts.) By setting this

value higher, the device requires more weight to be shifted to the foot by the user

before it assists the user. The higher the percentage, the more difficult it may

become for the user to use the device properly. This setting can be adjusted at any

time and may need to be modified during different mobility activities depending on

the needs of the user.

Assistance factor is an approximate percentage measurement that refers to the

amount of support the device provides to the user to help with extension of the

lower extremity. This parameter has the most impact during standing up or going up

stairs. Typically a higher value will provide more assistance for users who need

more to accomplish a task.

Resistance factor refers to the support provided during descent (flexion moment)

that a user will experience during such tasks as sitting down or descending stairs.

The High setting can be used to perform eccentric strength training or when poor

control is present with knee flexion. The Low setting can allow the user to train in a

normalized knee flexion movement pattern.

Assist Cutoff sets the range of motion through which the device is active. . The

actual value set is the minimum angle of extension by the device. For example, if

the limit is set to 10° (which is equivalent to -10° extension), any extension of the

knee beyond 10° (e.g., 5°) would not be assisted by the device. The device does not

provide a hard stop to this angle.

All parameters are returned to the default values whenever the unit is powered on or

when the foot sensor is disconnected.

Disconnecting the foot sensor while paused also unlocks the device to allow it to be

fully flexed. Disconnecting the foot sensor before powering down allows the

device to be easily stored in the case.


116569 Rev B Page 25 of 53

4. Instructions for Use

4.1. Donning Instructions

4.1.1. User Guidelines

TABLE 7:USER SIZE GENERAL GUIDELINES

Measurement Measurement Details Recommended Range

Weight N/A 110 – 300 lbs

(50kg – 135 kg)

Height N/A 5’0” to 6’0”

(152 cm to 183 cm)

4.1.2. Positioning

Ideally, the user should be positioned in a comfortable

seated position with the target knee in a flexed position.

4.1.3. Fitting and Applying the Shoe Insert

It is recommended that the user always wear comfortable,

supportive shoes with wide footing while using the Bionic

Leg. Boots and high-top shoes will interfere with the

attachment of the exoskeleton to the shoe insert stay and

therefore cannot be worn with the device.

Each Shoe Insert can be used on the right or left foot

interchangeably, by flipping it over, and comes in four

sizes. See Table 8 for a conversion chart for shoe insert

sizing.

TABLE 8: SHOE INSERT SIZING

Shoe Insert Size Women’s Shoe Size Men’s Shoe Size

XS US Size: 4 to 6½

EU Size: 35 to 37 N/A

S US Size: 7 to 9

EU Size: 38 to 40 cm

US Size: 6 to 8


M US Size: 9½ to 11


US Size: 8½ to 10½


L US Size12

EU Size: 43 cm

US Size:11 to 16



116569 Rev B Page 26 of 53

Once proper size has been identified, slip the Shoe Insert into the patient’s shoe.

Make sure that the Footpad is sitting flush with the shoe insole. If the user has a

custom orthotic that is interfering with the proper placement of the Shoe Insert, it

may be removed during training if the patient can adequately maintain proper foot

position in stance.

Similarly, when using an ankle-foot orthosis (AFO), the Shoe Insert should be

placed in the shoe first, followed by the foot wearing the AFO. The outer portion

of the Velcro stays must be exposed for attachment to the lower stays of the

orthosis.

After the Shoe Insert is in position, the user’s foot can

be placed into the shoe.

Adjust the of the ankle wings so they are aligned with

the malleoli. Visually verify alignment. Additional

padding may be placed around a lean leg/ankle for

comfort.

The outer portion of the Velcro stays must be exposed

for attachment to the lower stays of the orthosis. The

user’s clothing must be positioned on the inside of the

anklet.

SAFETY WARNING

Footwear must be worn when using the AlterG Bionic Leg. Failure

to do so may affect device performance and/or cause injury to the

patient.

ATTENTION

• If the Footpad is not fitted properly (e.g., Footpad is wrinkled or folded under

the foot or too long), the device may be unable to gather correct information

from the sensors and therefore, may not perform as expected.

• Always store the Footpad in a place where it can remain flat. While the

Footpad is designed to flex under the user’s foot, avoid bending or folding the

Footpad in order to prevent damaging the embedded sensors.


116569 Rev B Page 27 of 53

NOTE

• Users should wear appropriate, comfortable and supportive shoes while using

the Bionic Leg, e.g., low profile athletic shoes or walking shoes.


116569 Rev B Page 28 of 53

4.1.4. Device Preparation

The most efficient manner to fit the Bionic Leg is to start with making adjustments

to the exoskeleton in order to prepare the device prior to fitting it to the user.

• Open all three textile segments from the device by

separating the Velcro patches and opening the

textile straps.

• Open all cable reel knobs. Pulling out the knob and

verifying that a red marker is visible on the “neck”

of the knob. Additionally, a snap sound should be

heard when pulling out or pushing in the knob.

Check to make sure that the cables can be pulled

smoothly through the mechanisms and that none of

the cables/patches have been twisted.

4.1.5. Textile Fitting

• Have the user sit near the edge of the seat to allow

access to the entire thigh.

• Place the housing portion of the device on the

user’s thigh, as proximal to the groin as possible,

and align the orthosis hinges around the knee

axis.

• Insert the Footpad Cable located on the distal end

of the orthosis into the mating connector attached

to the Shoe Insert.


116569 Rev B Page 29 of 53

• Snugly wrap the Lower Leg Textile around the

calf and attach the corresponding Velcro sections

to one another. Verify that the lower leg portion

of the device is aligned properly and attached to

the Velcro on the Foot Insert ankle wings. Verify

that the user’s ankle can be dorsiflexed without

interference from the textiles.

• Wrap the Knee Textile around the back of the

knee, as snug as possible, and attach Velcro.

• Next, snugly wrap the Upper Leg Textile around

the thigh and attach the corresponding Velcro

sections to one another.

• While wrapping the textiles, make sure that the knee maintains its position in

the orthosis and remains centered.

• Confirm that the device housing is placed centrally on the user’s leg. Adjust the

device if necessary.

Knee is centered and anterior in brace

Clearance and coverage at ankle


116569 Rev B Page 30 of 53

4.1.6. Cable and Reel System Fitting

A snug fit of the textiles is necessary for effective support from the Bionic Leg to

the user’s leg. For optimum performance, it is important to tension the cable

systems securely; excessive tightening (constriction) should be avoided.

• Verify that the Bionic Leg did not rotate on the thigh during the above process;

if rotated, realign the device. Once properly aligned, tighten the device first at

the lower leg followed by the thigh region.

• Secure the textiles around the calf by pushing IN (a snap should be heard) on

the lowest reel knob, and turning clockwise. This will apply tension to the

cable system and secure the textiles around the lower leg. Tighten the cable

system until it is as tight as comfortably possible.

• Next secure the textiles around the thigh by pushing IN on the upper-most and

middle reel knobs

• Verify the user’s comfort level. Excessive constriction should be avoided.

SAFETY WARNING

Do not use the device if the user has fragile skin, open wounds, sores or

blisters in the vicinity of where the device will be placed.

Avoid over-tightening any part of the device around the leg. This may

reduce blood circulation to the limb and potentially cause swelling,

paresthesia (tingling or numbing), blood clots, or other symptoms.

For users with impaired sensation of the lower extremity, caution should

be taken during the tightening process. This is accomplished by

inserting fingers between the textile and user’s limb to assess cable

tension and potential for discomfort.

Avoid direct skin contact with the cables. Cable guides, in addition to

guidance Velcro patches on the posterior of the textile, should be

adjusted to prevent cable-skin contact.

Verify that the cable reel knobs do not rub against the opposite thigh.

Usage should be discontinued if irritation occurs on the opposite leg.

Placing a neoprene sleeve or wrapping on the opposite thigh with elastic

wrap may mitigate the rubbing effect.


116569 Rev B Page 31 of 53

NOTE

• The Bionic Leg is to be placed over the user’s clothes or suitable protective

barrier. Do not allow the device to come into direct contact with the user’s

skin.

• A comfortable level of tightness, as secure as possible without over

constriction, should be achieved using the cable reels. If the device is too loose

it may impact the ability of the device to efficiently transfer assistance force.

• Continuous activity with the Bionic Leg will cause the cable system to loosen.

Thus, the cable reels should be intermittently tightened during extended use.

4.2. Removal Instructions To remove the Bionic Leg, have the user sit with the device still in Active Mode.

Press the Home Button to change the device state to Standby (Home screen will

appear) before fully removing the device. The device does not need to be powered

off before removal.

To remove the Bionic Leg:

• Disconnect the Footpad Cable Connector at the ankle.

• Release all four cable reels by pulling OUT on the knobs (a snapping sound

should be heard). The textiles will loosen around the leg.

• Release all Velcro attachments. Separate lower leg orthosis and ankle

wings.

• Lift device off the leg and place it in a safe location.

• Remove the user’s shoe and remove the Shoe Insert.


116569 Rev B Page 32 of 53

4.3. Set-Up Instructions Note: At least ten walking steps must be the performed for the device to

calibrate to the user’s movements.

Once the device has been fitted to the user, it is ready to be configured. Turn the

device on as instructed above. The device will initialize and the Home menu screen

will appear. The function of the four select buttons will activate the action labeled

in the corresponding corner of the display screen. The functions will change

according to the commands shown on the screen.

• From the Home screen press Settings using the

lower left soft key. The “Settings” menu allows the

clinician to set the five parameters for the user.

• NOTE: If no other parameters need to be set, press

the “Home” button at any time to return to the Home

menu screen.

Weight

• When the Settings menu is selected, Weight

will display automatically with the current weight

setting.

• To modify, use the +10 and -10 increment buttons

(or +5 and -5 if set to kilograms) to enter the user’s

weight.

• When finished entering the Weight value, press

the top right soft key .

•

Threshold

• Use the +5 and -5 increment soft keys to enter the

desired value.

• When finished entering the Threshold value, press

the top right soft key .

Assistance


desired value.

• When finished entering the Assistance value,

press the top right soft key . If the assistance limit

is reached, then the value will turn orange.


116569 Rev B Page 33 of 53

Resistance

• Use the + and - soft keys to select the desired value.

• When finished entering the Resistance setting,

press the top right soft key .

Assist Cutoff


desired value.

• When finished entering the Assist Cutoff , press

the top right soft key to examine all settings.

Then press or the home button to return to

the Home screen.


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4.4. Clinical Application

4.4.1. Operating Mode: Active Assistance Mode

To verify the settings of the device, perform the following:

• Select the Settings soft key. Review each

parameter by using the top arrows to scroll through

parameters. To return to the main screen, press the

Home button

• To adjust a parameter during a session, press the Pause

soft key or Home button to exit Active

Mode. Press the Settings soft key to begin

modifying the settings. To return to the active state,

press the Home button and Start soft key .

• To exit Active Mode, press the Pause soft key or

Home button

• To activate the device from the Home screen, select

Start . The device will then immediately enter

Active Mode, and the screen will display the

cumulative number of Reps/Steps taken with the

device. This value is reset to zero each time Active

mode is entered.

• The Reps/Steps counter records the movements

performed by a user while wearing the Bionic Leg

when Active Mode is activated.

• A “Step” is when the user shifts approximately 10-

15% of their body weight on to the device’s Footpad.

This value is independent of the entered Threshold

value.


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• A “Rep” occurs when the sensors detect 10 to 15% of

the entered body weight and the knee angle of the

exoskeleton moves past 45 degrees for a combined

extension and flexion of the knee joint. Thus, when a

user moves from sitting to standing to sitting from a

standard height chair, the device Reps/Steps counter

will increase by one.

• Pressing the Home button at this point will stop the

device and return the display to the Home screen.

At the beginning of each session, place the device in Active Mode and direct the

user to stand and sit in order to become familiar with the device. Instruct the user to

walk with the device.

SAFETY WARNING

Read and understand the User’s Manual for the Bionic Leg before using this

device.

Use the Bionic Leg only within the range of motion and level of assistance that

is safe for the user’s condition.

Always use caution and remain in close proximity to the user when training

and when used on stairs. Instruct users to use a railing or supportive aid when

using the Bionic Leg on stairs.

Discontinue use of the Bionic Leg if the user experiences irritation, swelling,

blistering, pain, or similar symptoms from wearing the Bionic Leg.

Discontinue use of the device if the user has sustained an injury that affects

their ability to use this product safely.

Use the main power switch to turn off the device if you suspect the device could

be overheating. Use the Standby power button to stop the device if it is

operating in a way that inflicts pain or may cause harm. Remove the Bionic

Leg immediately and contact AlterG Customer Service.

ATTENTION

Exercise caution and use good clinical judgment when using the Bionic

Leg.


116569 Rev B Page 36 of 53

NOTE

• Users should not perform high-impact activities such as running or jumping

activities while wearing the Bionic Leg.

• Closely monitor the user when walking on non-level surfaces, over obstacles,

gravel, sand, or rocks while wearing the Bionic Leg.

• The Settings soft key can be depressed while in Active Mode to stop the

device and allow for the settings to be adjusted. To return to Active Mode press

the Home button and then the Start soft key .

4.5. Additional Interface Features In the top menu there are several screens that provide additional information.

Information screens include the AlterG customer service phone number, the device

identifier, serial number and the software firmware version. Additionally,

interactive screens include Service Mode and Expert Menu. Use the top soft keys

above the directional arrows to scroll through each screen. These screens are

described below.

4.5.1. Customer Service Information

The information on these screens should be provided to AlterG Customer Service if

issues arise with the device.

4.5.2. Restore Default Settings

The entire set of default settings will be restored at any time the device is powered

back on or when the foot sensor is disconnected

The default settings follow the “Mod” description on the Quick Start Guide,

including the following parameters:

Weight: 110 lbs.

Assistance: 45%

Resistance: 2 (Med)

Threshold: 25%

Assist Cutoff: 6°


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4.5.3 Select Weight Units

This screen sets the device to display either Pounds or Kilograms. To select the unit

press the soft key under either KG (kilograms) or LB (pounds.)

4.5.4 Device Usage

This screen displays the cumulative number of Usage Hours and Reps/Steps taken

with the device. The Usage Hours feature records the time the device is in Active

Mode. These values can only be cleared by AlterG Customer Support.

4.5.5 Expert and Calibration Menus

These screens are for AlterG Customer Service use only. They are used for device

maintenance and are password protected. Users should not attempt to access or

change any settings via these screens.


116569 Rev B Page 38 of 53

5. Removable Battery and Battery Charger

5.1. Battery Type The AlterG Bionic Leg uses a removable, rechargeable

Lithium Ion battery as its power source. Only AlterG

Lithium Ion Batteries (P/N: 19-00015-00) should be used

with Bionic Leg. Batteries can only be charged in the

AlterG Battery Charger.

5.2. Battery Capacity The amount of time that the Bionic Leg will operate with a fully charged battery

will vary depending on the activities performed and the size and weight of the user.

The battery will drain faster when used during high intensity and high repetition

activities (i.e., higher functioning users walking quickly on a treadmill). Users

should pay attention to the battery status icon on the Display Screen to know

battery levels and when to replace the battery. It is recommended that a fully

charged battery be used with each new session.

5.3. Specifications, Environmental and Safety

TABLE 9: SPECIFICATION AND OPERATIONAL ENVIRONMENTS

Specification Value

Rated Nominal Voltage 11.1V

Battery Capacity (typical) 1,500 mAh

Environmental Factor Range

Operating Temperature -22° to 40°C (-4°to 104°F)

Storage Temperature < 35°C (95°F) – do not store in direct sunlight

5.3.1. Battery Disposal

Check your local ordinances regarding disposal of Lithium Ion batteries before

disposal. Alternatively, the battery may be returned to AlterG for recycling.


116569 Rev B Page 39 of 53

5.4. Changing the Battery To change the battery, do the following:

• Locate battery latch on housing of device.

• Gently lift the latch to remove the current battery. As the latch moves the

battery will slide upward.

• Grasp the battery and slowly remove it from the housing.

• Insert the new battery with the connector facing inward. Align the battery with

the receiving hooks on the latch.

• Once aligned, gently push the latch down to secure the battery. If latch does not

easily close, verify that the battery is positioned properly on hooks of latch.

The latch will close only if the battery is properly positioned.


116569 Rev B Page 40 of 53

5.5. Battery Charger Use only approved AlterG Battery Chargers (115014) when charging your batteries.

The Cord and Power Supply connect to the back of the Battery Charger.

TABLE 10: CHARGER POWER SUPPLY VOLTAGE

Specification Value

Rated Power Supply Output DC Voltage and

Current

24.0 VDC; 3.75A

Rated Power Supply Input AC Voltage and

Frequency

100-240 VAC; 47-63Hz

Individual Charging Receptacle

DC Voltage and Current

12.4-12.6 VDC; 1.5 A [max]

5.6. Charging the Battery A green LED will illuminate when a battery is placed in a battery receptacle. If the

battery is not fully charged, the green LED will continually flash green until it’s

fully charged. It may take up to 45 min to fully charge a battery. Batteries can be

left in charger for storage. The Battery Charger LED Symbols outlined in Table 11

show the possible status of each receptacle.

5.7. Battery Labeling

TABLE 11: BATTERY CHARGER LED SYMBOLS

Specification Value State Description

Fully Charged

Solid Battery is fully charged.

Charging

Flashing Battery is charging

When the charging light continues to flash after several hours, it indicates that the

battery is near the end of its service life. Batteries that cannot be fully charged may

not provide full-length therapy sessions and should be replaced. Contact AlterG

service to obtain a replacement.


116569 Rev B Page 41 of 53

TABLE 12: BATTERY AND CHARGER LABELING

Label Location

Applied to Battery

Applied to Battery

Charger

SAFETY WARNING

Always follow safety precautions when using electrical products in order to

avoid electric shock, burns, or fire.

Do not use the Battery Charger or the Power Supply if either appears

damaged or is not working properly.

The Battery (P/N: 19-00015-00) contains Lithium. The Battery must be

disposed of or recycled in accordance with local regulations. Do not expose the

Battery to fire.

The Battery Charger may only be used with the AlterG Power Supply

(115014).

The Battery Charger may become warm during charging. Always keep the

Battery Charger in a cool area, away from external heat sources and direct

sunlight.

Keep the Battery Charger and Power Supply away from external heat sources.

Do not immerse the Battery, Battery Charger, or Power Supply in water or

expose to liquids.

Always remove the Battery from the Bionic Leg when the device is shipped.


116569 Rev B Page 42 of 53

Do not open the Battery Charger or Power Supply case.

NOTE

• The charge icon on the Bionic Leg is not a precise indicator of the remaining

charge. Whenever possible use a fully charged battery for each therapy session.


116569 Rev B Page 43 of 53

6. Environmental and Safety Conditions

6.1. Operating Conditions The Bionic Leg can be operated under the following conditions:

TABLE 13: OPERATING CONDITIONS

Operating Temperature 10°C to 40°C (50°F to 104°F)

Humidity 30% to 75% RH, non-condensing

6.2. Storage and Transportation The AlterG Bionic Leg must be stored and transported in the following conditions:

TABLE 14: STORAGE/TRANSPORT CONDITIONS

Temperature -20°C to 55°C (-4°F to 131°F)

Humidity 10% to 85% RH, non-condensing

The device should be protected against shock and vibration during transportation.

Contact AlterG for shipping container.

6.3. Safety Specifications The AlterG Bionic Leg is TUV certified by TUV Rheinland for

compliance to the standards:

IEC 60601-1:1988 + A1:1991 + A2:1995; CAN/CSA-C22.2 No.

601.1-M90; and UL 60601-1:2003 R4.06.

6.4. Care and Maintenance

6.4.1 Maintenance

The Bionic Leg is designed so that no periodic adjustment or calibration is required.

However, a routine visual inspection of the device should be conducted monthly to

confirm the textile attachment screws are present and not loose or tearing the

textile. If any of these conditions are present, contact Customer Service (510) 270-

5369.


116569 Rev B Page 44 of 53

6.4.2 Cleaning Instructions

The external surface of the Bionic Leg,

removable battery and Shoe Inserts can be

cleaned with a germicidal disinfectant wipe.

During cleaning no liquid or cleaning cloth

should be placed in the slots near the battery

terminals. None of the components should be

saturated or immersed in liquid. The device

should be cleaned on a regular basis.

SAFETY WARNING

Never shower or expose the Bionic Leg to running water or

submerge in water.

Never attempt to open, dissemble, modify, or repair any component

of the AlterG Bionic Leg, including the accessories. Contact AlterG

Customer Service for all service concerns.

If the device has a malfunction, remove the external battery or use

the main ON/OFF switch to disconnect power from the battery and

contact AlterG Customer Service.

If the device becomes too warm, turn off the device using the main

ON/OFF switch. Remove device from the user and contact AlterG

Customer Service.

ATTENTION

• Handle this product with care. Avoid dropping or hitting the device against

hard surfaces.

• Store the device in its protective case in a clean, dry, cool location.

• Avoid storage locations subject to excessive temperatures or humidity.

• Follow the instructions in this manual to clean the device.

• Do not saturate or submerge the AlterG Bionic Leg and its accessories in

liquid of any kind.

• The Bionic Leg generates, and can radiate radio frequency energy. If not

used in accordance with the manufacturer’s instructions it may cause harmful

interference to other devices in the vicinity. The device has been tested and

complies with the emission standards EN60601-1-2.


116569 Rev B Page 45 of 53

7. Troubleshooting

7.1. Error Codes When device errors occur an Error Code will appear on the display screen. Error

codes will momentarily display but will not interfere with operation. Some errors

will require user interface to clear. Others will be permanent and require user to

contact AlterG Customer Service for repair.

TABLE 15: Errors and Warnings

Icon Meaning Error

Number Description

Low Battery 6x

Low battery warning or error. If

encountered while running, the

device continues to operate until the

battery is very low.

Foot Sensor

Unplugged 400

The foot sensor was unplugged

when the run button was activated.

Foot Sensor

Error 36x

The foot sensor is bad or was

unplugged while in Active Mode.

Force Limit 26x, 38x

Internal force or torque warning.

Too much force was applied to the

device. Usually encountered when

the patient rapidly sits down with all

weight on device. This warning is

displayed for 8 seconds, the device

beeps, then automatically resets

itself. The device continues to be

active the whole time.

!

!

!

!


116569 Rev B Page 46 of 53

Other Errors

7x. 8x,

22x

9x, 13x,

17x, 24x

10x, 14x.

15x, 20x,

27x,

210x, 25x

16x, 23x,

25x

18x, 19x

Mechanical error

Electronics error

Motor error

Initialization or calibration error

Software or factory configuration

error

7.2. Operational Issues

TABLE 16: OPERATIONAL ISSUES

Situation Parameter Relevance Resolution

Device

prematurely

activates (Occurs

primarily in sitting

or on the stairs or

when device is first

placed into Active

Mode.)

Threshold

The Threshold has

been set too low.

The amount of

weight being

applied on the foot

sensor(s) is too

great, causing the

device to extend

before the user is

prepared.

Un-weight foot to remove

pressure. Press Home

button to deactivate

Active Mode. Raise the

Threshold parameter until

issue is resolved.

Device

Calibration

The device may

need to recalibrate

to the new settings.

More repetitions are

needed to interpret

the information

from the sensors in

the Footpad.

Have the user perform 5 -

10 steps (walking) with the

device.

Device appears to

be delayed, slow or

sluggish

Threshold

The Threshold has

been set too high.

The user is not able

to apply the proper

amount of weight to

activate device.

Lower by 5%. If still

unresolved, verify that the

Footpad is operating

properly.

!


116569 Rev B Page 47 of 53



Assist % or

Resist Level

The Assistance is

set too low and/or

Resistance is set too

high for user’s

ability.

Increase Assistance and/or

decrease Resistance

setting. Note: Some user’s

may not be successful if

setting > 60-70%.

Battery

Power

Level

The battery charge

level is too low. An

audible tone will be

heard when the

battery level drops

significantly.

Replace battery with a

fully charged battery. If

error continues to occur

verify battery is charged

and attempt different

battery. If a charged

battery does not clear the

error, contact AlterG

Customer Service

Device is not

operating as

expected. Either

activating too soon,

too late or

intermittently

during the mobility

task.

Calibration

The device needs to

calibrate to the new

settings.

Have the user take 10

steps. If still unresolved

check foot sensors (see

below).

Foot

Sensor

The Shoe Insert

needs replacement.

The device is not

receiving consistent

and/ or appropriate

information from

sensors.

After session, check

sensors on Footpad.

Connect suspected

Footpad to device and

activate Active Mode.

Gently press each sensor

one at a time. When the

sensors are pressed the

device should activate. If

no or reduced activation

occurs, then the Footpad

has failed and the Shoe

Insert should be replaced.

Threshold

The value is either

set too high or low.

The user is not able

to apply the proper

amount of weight to

activate device at

the proper time.

Adjust the Threshold to

allow for proper activation

to occur.


116569 Rev B Page 48 of 53



AFO use or

Tone/

Spasticity

Interference may

occur with weight

bearing in foot and

the user is not able

to shift or apply the

proper amount of

weight to activate

the device at proper

time.

Adjust Threshold and user

weight parameters to see if

corrections can be made. If

not, it may be necessary to

remove AFO or modify

intervention to allow for

improved user control.

Device provides

insufficient knee

extension during

use.

Assist

Cutoff

Assist Cutoff angle

is set too high and

the device is not

providing enough

assistance to fully

extend the user’s

knee.

Increase the Assist Cutoff

angle range (e.g. change

from 10 degrees to 5

degrees).

Note: It is possible for the user to override this motion by stopping their movement and

actively bending their knee. The device will stop assisting knee extension and allow knee

flexion.

Device is

intermittently

activating in static

and dynamic

standing and

cannot be

controlled by user.

Assist

Cutoff

Assist Cutoff is set

beyond the user’s

controllable end

range. The user is

shifting weight off

of the foot sensors.

Decrease the Assist Cutoff

(e.g. change limit from 5

degrees to 10 degrees).

Have user shift weight

over foot and attempt to

fully straighten limb until

device is quiet.

Note: This fluttering may be a desired effect to provide audible and tactile input to user in

static and dynamic stance activities.

Device is not

providing

sufficient

assistance to user

during extension

activities.

User’s

Weight

The value has been

set too low.

Insufficient power is

being provided to

assist with knee

extension

Check to make sure that

accurate body weight has

been entered.

Assist %

The Assist

parameter is set too

low. Device is not

providing enough

assistance to the

user.

Increase Assist parameter

by 10% increments up to

90%.


116569 Rev B Page 49 of 53



User is being

thrust into

extension

Adjust % or

User

Weight

Setting

Assist % or weight

is set too high.

Check to make sure that

accurate body weight has

been entered. Decrease

Assist by 10% increments.

Assist

Cutoff

Assist Cutoff is set

too high.

Decrease range of Assist

Cutoff (e.g. from 5 to 10

degrees).

Knee won’t flex in

swing phase

Foot sensor

The device remains

engaged in

extension, possibly

due to bend in the

Footpad or bad

sensor

Check to ensure Footpad is

lying flat in shoe with no

bends and/or tears. Try

another pad. If problem is

unresolved contact AlterG

Customer Service.

Power/

Active

Assist

Mode

Possible complete

power failure, error

or inadvertent shut

off of Active Mode.

If device is off power up

using the Standby power

button.

Clear any errors if

appropriate. Attempt to

access Active Mode again.

If unable to correct,

contact Customer Service.

Device does not

turn ON when

Standby power

button is pressed.

Main Power

Switch

Main power switch

may have been

turned to OFF

which disables the

device.

Check main power button,

move switch to icon with

dot within circle position.

Press Standby button,

device should turn ON.

Battery

Power

Battery power may

be too low to turn

on device.

Replace battery with fully

charged battery. If error

continues to occur verify

battery is charged, attempt

different battery and if still

unresolved contact AlterG

Customer Service.


116569 Rev B Page 50 of 53

7.3. Fitting Issues

TABLE 17: FITTING ISSUES


Device rotates

on user’s leg

during

operation.

Cable Reel

System

The cables have not

been tightened

adequately to

prevent rotation.

Tighten cables.

Lower leg and

ankle stays

The exoskeleton has

not been aligned

properly with ankle

Stays.

Realign each Stay at ankle.

Be sure to have the Stays

posterior to the ankle.

User complains

of discomfort.

Cable Reel

System

Cables may be too

tight.

Release knobs and re-adjust

cable tightness.

Additionally, one may need

to “smooth” the user’s skin

that could be pinched when

cables are tightened.

Tibial Plate

(lower leg

plate)

The tibial plate

length may be too

long or too short.

Adjust length of plate.

Device slides

down user’s leg

during

operation.

Textiles

The textiles have not

been wrapped

snuggly around

limb. Lower leg

Textile/ Exoskeleton

may not be properly

aligned at ankle (too

short and not

overlapping ankle

stays.)

Rewrap textiles snuggly

around limb. Lengthen

lower leg textile to ensure

adequate overlap of stays at

ankle. Make sure Velcro at

ankle stays is accessible and

sufficiently covered by

lower leg exoskeleton stays.

If absolutely necessary,

apply elastic wrap around

ankle stays to minimize

“bowing” effect.

Orthosis

The thigh portion of

exoskeleton was not

placed high enough

on limb. Poor

alignment at knee

axis.

Keep upward pressure on

hub portion of exoskeleton.

May ask user for assistance.

Check position on thigh;

align parallel to floor to

prevent slippage during

fitting.

Tibial Plate

(lower leg

plate)

The tibial plate has

not been lengthened

fully.

Lengthen plate.

Cable Reel

System

The cables have not

been tightened

adequately to

prevent slipping.

Tighten cables until device

is secure (i.e. cable tension

similar to a guitar string)


116569 Rev B Page 51 of 53

8. Warranty and Service

8.1. Warranty AlterG warrants that, for a period of one (1) year from the date of initial shipment

to Buyer and under normal and intended use and service, the Products shall be free

from defects in material and workmanship and shall substantially conform to any

specifications therefore agreed to in writing by AlterG or, if no such specifications

exist, the specifications then generally provided by AlterG to the public in its

Product literature. In no event does AlterG warrant that any software included in or

with the Products is error free. Excluded from this limited warranty are expendable

components, parts and supply items, including, without limitation, textiles and shoe

inserts. Buyer’s exclusive remedy and the entire liability of AlterG under this

limited warranty is for AlterG, at its option, to replace or repair the defective

Product or component thereof (in which case AlterG shall pay shipping charges

back to Buyer) or to issue a credit or refund to Buyer for the purchase price of the

Product (without interest). All Products or components replaced by AlterG shall

become the property of AlterG.

AlterG’s obligations under this limited warranty are subject to the satisfaction of all

of the following conditions: (i) AlterG is promptly notified in writing by Buyer of

such warranty claim during the warranty period, (ii) such warranty claim did not

arise as a result of misuse, abuse, accident, use of unauthorized accessories, impact

of faulty electrical power or other external causes, improper storage, transportation

or handling, reasonable wear and tear, or repair or alteration by anyone other than

as authorized by AlterG, (iii) Buyer complies with the return provisions of Section

6 above, and (iv) the serial number on the Product was not removed or altered. Any

replacement Product shall be warranted for the remainder of the original warranty

period or thirty (30) days, whichever is longer. AlterG shall in no event be

responsible for any labor or other costs incurred by Buyer incident to the

replacement of any defective Product. The limited warranty set forth above shall

extend to Buyer only and not to any third party. No person is authorized to make

any warranty or representation on behalf of AlterG concerning the Products other

than the limited warranty set forth above.

DISCLAIMER: OTHER THAN THE LIMITED WARRANTY SET FORTH

ABOVE, TO THE MAXIMUM EXTENT PERMITTED BY LAW, ALTERG

SPECIFICALLY DISCLAIMS ANY AND ALL EXPRESS, IMPLIED OR

STATUTORY WARRANTIES, INCLUDING THE IMPLIED WARRANTIES OF

FITNESS FOR A PARTICULAR PURPOSE, OF MERCHANTABILITY AND

AGAINST INFRINGEMENT.


116569 Rev B Page 52 of 53

8.2. Customer Service When a device problem occurs that is unresolved in the field and it becomes

necessary to return the device for servicing, follow the procedures below:

• Contact Customer Service at 1-510-270-5369 for technical product support.

• If problem cannot be resolved over the phone, Customer Service will send a

replacement unit or provide instructions for return of the Bionic Leg for

service.

• Do Not return the device without contacting Customer Service first. No devices

will be accepted that do not have a Return Material Authorization (RMA)

number attached.

• AlterG will replace, at no charge, consumable components (i.e. shoe inserts,

rechargeable batteries) with less than 60 days of ownership. If greater than 60

days, replacement items are available for purchase through Customer Service.

• If the Bionic Leg or the case for the Bionic Leg appears damaged upon receipt,

please contact Customer Service.


116569 Rev B Page 53 of 53

9. Contact

European Authorized Representative

Obelis s.a.

Bd. Général Wahis 53

B-1030 Brussels, Belgium

Phone: 32.2.732.59.54

Fax: 32.2.732.60.03


AlterG, Inc.

48438 Milmont Dr.

Fremont, CA 94538

www.alterg.com

Office: 1-510-270-5900

Support: US: +1.510.270.5369

UK: +44 (0)7733 179187

Fax: 1-510-225-9399


mailto:[email protected]

http://www.tibion.com/

Documents

Bionic Leg Orthosis User Manual - AlterG · AlterG Bionic Leg User Manual 116569 Rev B Page 4 of 53 1. Purpose 1.2. Indications for Use The AlterG Bionic Leg Orthosis is designed